IMG-7289 in Patients With Myelofibrosis

Imago BioSciences,Inc. (Industry)
Overall Status
Completed ID

Study Details

Study Description

Brief Summary

This is a Phase 2b open label study of an orally administered LSD1 inhibitor, IMG-7289, in patients with myelofibrosis.

This study investigates the following:
  • The safety and tolerability of IMG-7289

  • The pharmacokinetics of IMG-7289 (performed in Phase 1/2a only)

  • The pharmacodynamic effect of IMG-7289

Detailed Description

With enrollment complete in Phase 1/2a, expansion into Phase 2b has occurred. New patients will be enrolled into Phase 2b study.

Study Design

Study Type:
Actual Enrollment :
89 participants
Intervention Model:
Single Group Assignment
None (Open Label)
Primary Purpose:
Official Title:
A Multi-Center, Open Label Study to Assess the Safety, Steady-State Pharmacokinetics and Pharmacodynamics of IMG-7289 in Patients With Myelofibrosis
Actual Study Start Date :
Jul 1, 2017
Actual Primary Completion Date :
Mar 8, 2022
Actual Study Completion Date :
Mar 8, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: IMG-7289

Single starting dose with individualized dose titrations throughout

Drug: IMG-7289
Differentiation therapy
Other Names:
  • LSD1 inhibitor
  • Outcome Measures

    Primary Outcome Measures

    1. Incidence of treatment-emergent adverse events, and changes in physical examination, vital signs and laboratory parameters [safety and tolerability] [Assessed from the time of first dose through 28 days after end of treatment.]

      as measured by the frequent monitoring of: adverse events, physical examination and vital signs and laboratory parameters.

    Secondary Outcome Measures

    1. Drug Concentration (performed in Phase 1/2a only) [Up to 3 months.]

      as measured by Cmin sampling.

    2. Spleen Volume [Baseline to each visit where the variable is measured.]

      Reduction in spleen volume based on MRI (or CT)

    Eligibility Criteria


    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    Inclusion Criteria:
    • 18 years

    • Diagnosis of either PMF per World Health Organization (WHO) diagnostic criteria for myeloproliferative neoplasms, PPV-MF or PET-MF per the IWG-MRT

    • High or intermediate-2 risk disease, as defined per protocol

    Exclusion Criteria:
    • Receiving other treatments for the condition (with exceptions and time limits)

    • Major surgery in last 4 weeks, minor surgery in the last 2 weeks

    • History of, or scheduled, hematopoietic stem cell transplant within 24 weeks of Screening

    • History of splenectomy

    • Current use of prohibited medications

    • A concurrent second active and nonstable malignancy

    • Known HIV infection or active Hepatitis B or Hepatitis C virus infection

    • Other hematologic/biochemistry requirements, as per protocol

    • Use of investigational agent within last 14 days

    • Pregnant or lactating females

    Contacts and Locations


    Site City State Country Postal Code
    1 University of Michigan Ann Arbor Michigan United States 48105
    2 Royal Adelaide Hospital Adelaide South Australia Australia
    3 Universitatsklinikum Essen Essen Germany 45147
    4 Azienda Ospedaliero Universitaria Careggi Florence Italy
    5 Guy's and St Thomas' Hospitals London United Kingdom

    Sponsors and Collaborators

    • Imago BioSciences,Inc.


    • Principal Investigator: Kristen Pettit, University of Michigan

    Study Documents (Full-Text)

    None provided.

    More Information


    None provided.
    Responsible Party:
    Imago BioSciences,Inc. Identifier:
    Other Study ID Numbers:
    • IMG-7289-CTP-102
    First Posted:
    May 2, 2017
    Last Update Posted:
    Mar 29, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Plan to Share IPD:
    Studies a U.S. FDA-regulated Drug Product:
    Studies a U.S. FDA-regulated Device Product:
    Keywords provided by Imago BioSciences,Inc.
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 29, 2022